- Drug and Medical Device stocks Appreciate in Value Before Big Clinical Trial Results and Clearances from the FDA or European Medicines Agency
- Investors who Recognize the Potential "Lightning Strike" Beforehand have Done the Best, Like with ALNY and MNKD Which Rallied 260% and 600% This Year Before Big Company Events
- BTCY is Approaching a Major Possible Lightning Strike Event with an FDA Clearance Upcoming for Their Bioflux Device, Which Could Send the Stock Rallying Higher
What better way to profit from the boom in biomedical stocks this year than to find companies with imminent market-moving events, trading at discounts to their peers.
We've identified Biotricity (OTCMKTS: BTCY) as an under-the-radar stock with huge upside potential in the next 3 months as the company awaits a decision from the United States Food And Drug Administration (FDA), possibly in December, on their unique remote heart monitoring device. Their application appears sound, and the market values similar companies in this industry at multiple times higher with approved devices like BTCY's. This company could be primed for significant upside.
Lightning Strike Events Send Biomedical Stocks Rocketing
Biomedical companies are known for big moves in their share prices accompanying events that change their potential future value. These "lightning strike" events can come in the form of drug or device approvals from regulatory agencies like the USFDA, opening them up to sales and even buyouts, or the European Medicines Agency in Europe. They can also be in the form of clinical trial results from the drug development or device testing process.
Many investors don't realize, though, that share prices for these product developers also appreciate BEFOREHAND. Once the lightning strikes, these stocks can already have appreciated by 50-100%!
The drug developer Alnylam Therapeutics (NASDAQ: ALNY) is a great example of the power in lightning strikes, especially for traders who saw what was coming.
From the beginning of 2017 to this week, ALNY rose by an immense 265% in expectation of new clinical trial results from their main experimental drug patisiran. The company announced a first look at the results in September but it wasn't until the first week of November that the company presented the full set of human results. They were impressive, profoundly helping adults with the disease hereditary ATTR amyloidosis. The complete results sent the share price rocketing higher by 13% even AFTER the stock had already appreciated almost 300% this year. That's the power of recognizing lightning strikes BEFORE they happen.
Another good example of biomedical stocks that appreciate into big lightning strike events is Mannkind Corporation (NASDAQ: MNKD). This maligned company hadn't done so well at selling their inhaled insulin product called Afrezza, which was approved by the USFDA in 2014. But investors started getting onboard this summer in anticipation of a change to the FDA's approved label for Afrezza showing how quickly this rapid-acting insulin works at meal-time based on some new clinical research presented in 2016. Between the spring and this FDA change in October, MNKD appreciated by a staggering 600%, from $1 to as high as $7 as investors recognized how meaningful this label change might be for the sales of Afrezza. Again, it was anticipating the lightning strike that allowed savvy investors to find amazing price appreciation in a biomedical stock.
A Completely Overlooked Event That Could Send BTCY Soaring
Biotricity is a small developer of remote monitoring technology, and they're on the verge of a big announcement. The company filed for USFDA 510(K) clearance-which is the "approval" of a medical device for the Bioflux MCT device (for mobile cardiac telemetry) in April 2017. This device provides real-time monitoring and transmission of ambulatory patients' ECG information and is used in the evaluation and diagnosis of certain heart conditions. Some competing but possibly inferior products on the market are doing immense sales already and investors have piled into these similar companies. IRhythm (NASDAQ: IRTC) is on track for sales of almost $100 million this year and has a huge market capitalization of $1.2 billion. One of the other pure-plays in this industry, BioTelemetry (NASDAQ: BEAT), is on track to generate over $220 million in sales from their cardiac monitoring business, and the company has a one billion dollar market valuation! Investors know that mobile monitoring and algorithmic services with these devices is a big and growing market.
Biotricity is on track to join these high-growth peers with an imminent decision from the FDA on Bioflux. The company heard back this summer that the software component of the device has been cleared for use, and now they're conducting some final testing of the external pouch used to carry the Bioflux device. Biotricity is confident in the material used since it has previously been tested under regulatory guidance. Once the company submits these results back to the FDA, they should learn more within two months, and they could be approved by the end of this year if all goes well.
Cardiac monitoring was a $22.2 billion market in 2016 across the globe, and this market is projected to reach $28 billion by 2021, driven by a growing obesity problem in the United States and improved technology making remote monitoring simpler and cheaper. Biotricity plans to make this even more attractive when they launch Bioflux next year by passing most of the financial returns from using Bioflux to the diagnosing physician-today these physicians see almost none of the revenue from using mobile devices! Lifewatch AG (SIX: LIFE) was bought by Biotelemetry for $260 million-almost 5x higher than BTCY-because of their MCT business. Biotricity's unique approach to sales and marketing could set BTCY up for big upside into 2018 with their FDA clearance and imminent launch.
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